美国食品药品管理局许可Onkos抗菌涂层扩围：NanoCept可用于ELEOS系统更多钛组件，为该涂层第四次510(k)许可
新泽西州布里奇沃特报道 — Onkos Surgical 公司获得美国食品药品管理局（FDA）510(k)许可，将其 NanoCept 抗菌涂层的使用范围扩大到 ELEOS 肢体保留系统（limb salvage system）的更多钛制组件，可应用的组件包括骨水泥型弧形节段柄、股骨近端、胫骨基座与增高块等，并可延伸至此前已获许可的其他钛组件。
据报道，NanoCept 是一种抗菌涂层，设计目的为减少植入物在手术室中、植入前经手处理与准备时表面可能沾染的细菌。该公司称，大量临床前评估显示，对手术室常见细菌的减少最高达99.9%。报道同时明确，该涂层并非用于治疗已形成的感染，且尚无人体临床试验评估其预防感染或降低感染风险的效果。
报道称，这是 NanoCept 自2024年4月获 FDA 首个从新（de novo）授权以来的第四次510(k)许可，此前2026年内已另有一次许可把其应用扩大至钛植入物。公司创始人兼首席执行官帕特里克·特雷西（Patrick Treacy）表示，此次许可支持该公司开发更多带抗菌涂层的植入物。带涂层组件由该公司位于新泽西州布里奇沃特的 NanoCept 创新中心制造。
FDA Clears Onkos NanoCept Antibacterial Coating for More Titanium Parts of the ELEOS Limb Salvage System in the United States, the Coating's Fourth 510(k) Clearance
BRIDGEWATER, New Jersey — Onkos Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the use of its NanoCept antibacterial coating across additional titanium components of its ELEOS limb salvage system. The clearance authorises NanoCept application to cemented bowed segmental stems, proximal femurs, tibial baseplates and augments, and allows the coating to be extended to additional titanium components that had previously received FDA clearance.
NanoCept is an antibacterial coating designed to reduce bacterial contamination on implant surfaces in the operating theatre before surgical insertion, targeting bacteria that may come into contact with implants during surgical handling and preparation. According to the company, extensive preclinical evaluations demonstrated up to a 99.9 percent reduction in bacteria commonly encountered in operating rooms. The coating is not intended to treat established infections, and human clinical trials have not evaluated its effectiveness in preventing infections or reducing infection risk.
The decision is the fourth 510(k) clearance for NanoCept since the FDA granted its initial de novo authorization in April 2024, following another clearance earlier in 2026 that expanded the technology to titanium implants. Founder and CEO Patrick Treacy said the clearance supports the company's efforts to develop a broader range of antibacterial-coated implants. Onkos manufactures NanoCept-coated components at its NanoCept Innovation Center in Bridgewater, New Jersey.
发布：GSM·美国（发布链接）
图片来源：图：髋关节置换术后X光片（资料图）。，经Wikimedia Commons。 / Photo: a postoperative hip prosthesis radiograph (file image). , via Wikimedia Commons.
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